Compact auto-injector

ABSTRACT

A novel single use auto-injector for delivering a fixed amount of medicament is described. The auto-injector may include a sealed housing rotatably held in a cover. Once the auto-injector is positioned at the injection location, the user can transition the housing from a locked to an armed position. The user can then compress the sealed housing into the cover, triggering activation mechanisms that initiate the injection. A first activation mechanism engages an interlock to prevent reuse of the auto-injector. A second activation mechanism straightens and extends a curved needle to a set the exposed needle length. A third activation mechanism pierces a sealed reservoir allowing the medicament to be forced through the injection needle. Following the injection, the auto-injector expands and interlocks, retracting the needle into the auto-injector and preventing reuse.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of priority to U.S. ProvisionalPatent Application No. 62/552,052 entitled “Compact Auto-Injector,”filed on Aug. 30, 2017, and U.S. Provisional Patent Application No.62/568,567 entitled “Protective Case for an Auto-Injector,” filed onOct. 5, 2017, the contents of both of which are incorporated herein byreference in their entireties.

TECHNICAL FIELD

The invention relates generally to medicament auto-injectors and, moreparticularly, to an auto-injector of a relatively low profile and highaspect ratio. The auto-injector allows for administration of a desireddose of medicament intramuscularly or subcutaneously.

BACKGROUND

The auto-injector market is growing rapidly through an increase inprescriptions, along with new indications for use. Auto-injectors arebecoming more dominant as they provide an innovative approach toadminister drugs or biological products, and they may enhance safety,improve dosing accuracy, and increase patient compliance, particularlyin self-administration settings.

Existing auto-injectors leave patients actively seeking an alternativeto address the anxiety they feel associated with existing pain points;poor portability, unwanted attention, accidental injections, andlacerations. An improved auto-injector is needed.

SUMMARY OF THE INVENTION

Through a human-centered design focus, embodiments of the auto-injectordescribed herein are portable, intuitive, and easy-to-use. Theauto-injector technology is diversely applicable to many indications foruses that require fixed dose, single-use intramuscular or subcutaneousinjections. Embodiments of the auto-injector are designed to considerthe human element. The enhanced ergonomics of embodiments of the device,in combination with the high aspect ratio injector technology, aredesigned to match modern lifestyles. Embodiments of the inventioninclude a high aspect ratio auto-injector technology that enables thecreation of a portable as well as wearable auto-injector for safe andeffective dosing of epinephrine, and other medicaments (note that theexemplary value ranges in the chart of FIG. 141 relate to the deliveryof multiple medicaments, but can be adjusted, as necessary, toaccommodate the delivery of other medicaments). FIG. 1 provides exampleillustrations of how the aspect ratio of an auto-injector is calculated,using both conventional auto-injectors and the inventive auto-injectordescribed herein. As used herein, and with reference to FIG. 1, height(H) is defined as the largest straight-line length of the auto-injectoraway from the skin during injection (perpendicular to the injectionsurface), and width (W) is measured as the smallest straight-line lengthon the surface that is in contact with a patient's skin during injection(parallel to the injection surface).

The novel auto-injector technology can be readily incorporated into anauto-injector that can be worn in a bracelet, pendant or other accessoryto ensure that the auto-injector is always within reach in the event ofan emergency. The objectives of a portable and wearable auto-injectorthat is safe, easy to use, as well as other objectives, will be apparentto those skilled in the art.

In one aspect, the invention is a compact auto-injector for delivering amedicament dose subcutaneously or intramuscularly. The auto-injector maybe composed of two main components: a sealed housing, and a cover.Disposed inside the sealed housing is a medicament reservoir containingthe medicament, a medicament dispensing system (MDS) and a needleextension system (NES). Upon time of injection, the medicament reservoirand needle extension system are in fluidic connection.

The sealed housing may be rotatably retained in a cover. In oneembodiment, the sealed housing may be rotated relative to the cover froman initial position, to a second position following a user input througha designed interface. At least one of the components comprising thesealed housing or the cover may include indicia indicating the first,second, or subsequent positions. The sealed housing may be boundedduring the transition such that the sealed housing may be displacedrelative to the cover in a controlled means. The auto-injector canfurther include a biasing member, whose function includes displacing thesealed housing relative to the cover. In various embodiments, thebiasing member can be a spring that is integrally formed with the sealedhousing or cover or conversely a separate component which can bedisposed between the sealed housing and the cover. The auto-injector mayfurther include an interlock, such that the sealed housing cannot bedisplaced unless the mechanism has been removed or released by the userwhen use of the auto-injector is required.

To assist the user in performing a proper administration, theauto-injector should be correctly oriented at the time of injection. Theauto-injector may assist orientation with labeling, tactile surfaces,material color or transparency, and other indicia indicating selectsides. Furthermore, the auto-injector may present itself with rotationalaids, whereas the aids can be contoured, textured, coated or combinationof such to further indicate orientation and operation. In addition, theauto-injector can include a viewing window into the internals of theauto-injector for medicament inspection which may further assist theuser in establishing orientation.

In one aspect the sealed housing is composed of two components; a topand bottom half that are mated together. Disposed inside the sealedhousing is a medicament reservoir containing the medicament, amedicament dispensing system (MDS), and a needle extension system (NES).The embodiment of the bottom half may provide an aperture for theinjection needle to pass through. The two halves, are of such geometrythat they may locate and secure the internal components. The two halveswhich comprise the sealed housing may provide a mechanism or interfacefor rotating the housing relative to the cover. In some embodiments thesealed housing may aid in determining the fixation location for the MDS,and the NES, as well as aid in the releasing of both systems at time ofinjection. Additionally, the housing may provide a feature fordetermining the angular displacement or rotation of the needle barrelthat the injection needle is affixed to. The sealed housing may aid inproviding alignment during the displacement relative to the cover.Furthermore, the two halves may each provide features to assist inassembly of the two halves to ensure the correct internal alignment. Thesealed housing can provide a means of bracing or supporting theinjection needle. In addition, the two halves may contain or align theinterlocks for preventing displacement of the sealed housing relative tothe cover, once the injection has been performed.

The medicament dispensing system (MDS) which dispenses the medicament iscomposed of a plunger, a biasing member, a retainer, and a keeper. Thebiasing member may be similar to a mechanical compression spring. Thespring may be held in a state preserving potential energy to be releasedat the time of injection. The retainer which displaces the plunger, maybound the spring on one end and may have a fixation point on theopposite end. The retainer may facilitate a self-fixation or be fixed inplace with a separate locking mechanism which may be released orunlocked at the time of injection. The keeper may bound the side of thespring opposite of the retainer and control the displacement of theretainer relative to the keeper. The displacement of the retainerrelative to the keeper is proportional to the volume of medicamentdispensed. The MDS may further include a dispensing needle coupled tothe retainer in constant fluidic communication to the injection needle.Once the retainer contacts the plunger, the dispensing needle piercesthe plunger and is in communication with the contained medicament, andtherefore, the medicament is in fluidic connection with the injectionneedle as well. Once released, the retainer further displaces theplunger to pump the dose out of the reservoir, through the dispensingneedle, through the fluidic connection, and through the injectionneedle. A flexible or combination of a rigid and flexible tube may beused to interconnect the dispensing needle with the injection needle.

In certain embodiments the needle extension system (NES) can include acurved injection needle, a needle barrel for supporting the curvedinjection needle, a needle barrel guide for aligning the needle barreland injection needle during administration, and a biasing member coupledto the needle barrel for rotating the needle barrel to straighten thecurved injection needle to deploy the distal end of the tissue. Thebiasing member may be a torsion spring. In some embodiments, the axis ofrotation of the needle barrel may be substantially perpendicular to alongitudinal axis of the medicament reservoir. The NES can include aneedle barrel cap, or another means of fixating or securing a proximalend of the injection needle to the barrel. Additionally, the needlebarrel cap may aid in securing the flexible tubing to the needle. Thebarrel cap and or barrel may provide a means of determining the startingand ending rotational position of the injection needle proportional tothe depth of injection. In certain embodiments the needle barrel may besecured with a locking mechanism to maintain the potential energy of thetorsion spring while held under load, to be released or removed at thetime of injection. Furthermore, the needle barrel guide may maintain theconcentricity of the needle barrel during the injection. The step oftriggering the deployment of the curved injection needle through theaperture in the housing can include manually compressing theauto-injector when the housing is aligned with the cover for aninjection and the rotation of the needle barrel to drive the distal endof the curved injection needle through the aperture. Advantageously, thestep of retracting the distal end of the injection needle through theaperture, results from releasing the manual compression of theauto-injector. Following the injection, the displacement of the sealedhousing relative to the cover may actuate an interlock, preventingfurther reuse of the auto-injector.

In certain embodiments the housing is protected by the cover whichprovides protection for the sealed housing during the storage of theauto-injector. The cover may also provide a means of bounding the sealedhousing, such that the sealed housing is displaced with respect to thecover in a controlled manner. In various embodiments, a biasing memberfacilitates this displacement of the housing relative to the cover. Thebiasing member can be a spring that is integrally formed with the cover,or sealed housing, or conversely a separate component which can bedisposed between the sealed housing and the cover. The cover may act orperform as the triggering mechanism for the injection. In addition toacting or performing as a protection and a triggering mechanism, thecover may also provide a stable base or platform to perform theinjection. The injection contact surface of the cover may provide atactile surface, which can facilitate the following functionalities:provide a stabilizing base for the auto-injector during injection, aidthe user in establishing orientation, as well as affix the auto-injectorto the injection location through the means of an adhesive layer orother attachment means. Furthermore, the bounding of the sealed housingby the cover may serve as a means of alignment during the injection.Once the sealed housing has been displaced relative to the cover toperform an injection, the cover will maintain alignment during themanual compression of the auto-injector from the armed to injectionposition to release the MDS and NES. The manual compression of thesealed housing while performing an injection, reduces the total heightof the auto-injector and causes the sealed housing to contact with theintended triggers or protrusions on the cover. The contact with thetriggers or protrusions between the cover and the sealed housing whileperforming an injection, due to the compression of the auto-injector bythe user may release the energy stored in the biasing members to bothdeploy the injection needle and dispense the medicament. Uponcompressing the sealed housing relative to the cover, the distal end ofthe injection needle will protrude past the cover, through an aperture,and dispense the desired dose. In some embodiments the cover may serveas a means of straightening the injection needle and provide a backingto support the injection needle during injection. In this manner, thelength of the injection needle that is deployed into the tissue can bestraight and perpendicular to the injection surface. Additionally, thecover can provide a means of guiding the sealed housing during themanual compression to aid in the alignment between the two components,to ensure proper release of the MDS and NES. Upon releasing the appliedcompression force, the biasing member displaces the sealed housingrelative to the cover, increasing the height of the auto-injector andretracting the distal end of the injection needle to conceal the needleand protect the user from accidental needle sticks. Advantageously, theauto-injector can include an interlock to prevent a subsequent manualcompression of the auto-injector, thereby rendering the auto-injectorsingle-use. The interlock can be an abutting structure in the housingand the cover. The method mentioned above includes the steps oftriggering deployment of the curved injection needle through an aperturein the housing, straightening of the injection needle, to embed thedistal end of the injection needle in tissue at a desired depth,triggering piercing of the medicament reservoir with the dispensingneedle to provide fluidic communication between the reservoir and theinjection needle, dispensing the dose through the injection needle and,thereafter, retracting the distal end of the injection needle.

In certain embodiments the auto-injector will be presented with a safetymechanism to be removed firstly before any subsequent operations. Theinjection surface may be exposed to the user once the safety mechanismhas been removed, further aiding in establishing an auto-injectororientation. The safety mechanism may also provide a means of preventingthe sealed housing from displacing relative to the cover prior toremoval, such that the injection sequence may not commence without firstremoving said mechanism. Alternatively, or additionally, the safetymechanism may protect the user from the injection needle if anaccidental discharge were to happen or remove a protective shroud orsheath that would perform a similar functionality. Therefore, theremoval of the safety mechanism may provide or facilitate the followingfunctionalities: establish orientation of the auto-injector, provide aninterlock to prevent the displacement of the sealed housing relative tothe cover prior to removal, protecting the user from the injectionneedle, removing a conjoined or coupled component that would furtherprotect the injection needle or user from said injection needle, as wellas protecting a tactile coating or surface on the injection contactsurface of the cover.

Prior to performing the injection, the injection needle in the NES andthe dispensing needle in the MDS may be covered or sealed to maintainpredetermined cleanliness criteria during storage of the auto-injector.Subsequently one embodiment of the auto-injector may provide the userwith protection from the distal end of the injection needle by the meansof a needle sheath. The needle sheath may fully encase the injectionneedle to prevent any contamination to the needle prior to use. In oneembodiment the needle sheath is used in conjunction with anothercomponent to protect the distal portion of the injector needle, whichwill be embedded in the tissue, from contaminants. The needle sheath mayalso provide a means to prevent the needle from injuring the user if anaccidental discharge were to occur. In other embodiments, the needlesheath may be fixed to the safety mechanism to aid in preventing anaccidental injection. The needle sheath may provide a means of fixationto aid in removal prior to use. In one embodiment the needle sheath hasa snap fit which allows the joining of the needle sheath to the safetymechanism to assist in removal prior to injection. Alternatively, theneedle sheath may only serve to prevent the injection needle from beingcontaminated and the safety mechanism can provide the user withprotection from an accidental discharge of the injection needle.

In some embodiments the auto-injector may have an internal power sourceto allow certain functionalities of the auto-injector during storage,during injection, and post injection. The auto-injector may provideaudible instructions for performing an injection. Additionally,connectivity of the auto-injector to everyday smart devices allows foradditional functionality. The connected smart device may display visualand/or auditory instructions for performing an injection. Certainembodiments may allow for the user to monitor the temperature, andlocation of the auto-injector. Additionally, the connected smart devicemay allow the user to see if other auto-injectors are nearby. Additionalembodiments may allow the smart device to contact emergency respondersor next of kin once an injection has been initiated. Furthermore,information about the auto-injector may be monitored remotely by themanufacturer.

In one aspect, the invention relates to a compact, high aspect ratioauto-injector for delivering a medicament dose subcutaneously orintramuscularly. The auto-injector can include a housing; a medicamentdispensing system disposed within the housing and including a medicamentreservoir adapted to contain the dose; and a needle extension mechanismcoupled to the medicament reservoir, the needle extension mechanismincluding a curved injection needle adapted to be straightened duringdeployment of the needle to facilitate dispensing of the dose by theauto-injector.

In some embodiments of the above aspect, the housing includes a sealedhousing rotatably retained in a cover. The housing can also include aninterface to receive user input to facilitate a manual rotation of thehousing relative to the cover from a first locked position to a secondunlocked position. In some cases, the housing, the cover, a label,and/or a component directly visible to the user includes indiciaindicating the locked position, the unlocked position, and an armedposition. The auto-injector can also include a biasing member, such thatwhen the housing is rotated to the unlocked position, the sealed housingis automatically displaced axially relative to the cover, increasing aheight of the auto-injector. The biasing member can include a springthat integrally formed with the housing integrally formed with thecover, and disposed between the housing and the cover. In someinstances, the auto-injector also includes an interlock, such that thehousing cannot be rotated relative to the cover or displaced axiallyrelative to the cover without removal of the interlock. In some cases,manual compression of the auto-injector in an armed position, reducesthe height of the auto-injector, and activates a mechanism thatstraightens and extends a distal end of the injection needle through thehousing, dispenses the dose through the injection needle, and activatesan interlock. In such cases, upon release of manual compression, thebiasing member can automatically displace the housing axially relativelyto the cover, increasing a height of the auto-injector and retractingthe distal end of the injection needle into the housing. Theauto-injector can also include an interlock to prevent subsequent manualcompression of the auto-injector, thereby rendering the auto-injectorsingle-use. The interlock can include an abutting structure in thehousing and the cover.

In some embodiments of the above aspect, the medicament dispensingsystem can further include a plunger within the medicament reservoir andforming a sealed cavity for retaining the dose. The medicamentdispensing system can include a dispensing needle in fluidiccommunication with the injection needle. In some cases, theauto-injector can include a flexible tube interconnecting the dispensingneedle with the injection needle. The medicament dispensing system canalso include a spring, a retainer, and a locking mechanism such thatwhen the locking mechanism is released, the spring displaces theretainer and forces the dispensing needle to pierce the plunger toprovide fluidic communication with the dose. In some cases, the coverincludes a second trigger to release the retainer and the lockingmechanism. The spring (e.g., a compression spring) may further displacethe plunger out of the vial and through the dispensing needle to theinjection needle.

In some embodiments of the above aspect, the needle extension mechanismcan also include a needle barrel for supporting the curved injectionneedle, a spring (e.g., a torsion spring) coupled to the barrel forrotating the barrel to uncoil the curved injection needle, and a barrellocking mechanism to prevent inadvertent rotation of the barrel. Thecover can form an aperture through which a distal end of the injectionneedle passes during rotation of the barrel to straighten the injectionneedle. In some cases, release of the barrel locking mechanism permitsthe spring to rotate the barrel and deploy the injection needle. In somecases, the cover includes a first trigger to release the needle barrellocking mechanism. The needle extension mechanism may also include abarrel cap to secure a proximal end of the injection needle to theneedle barrel.

In another aspect, the invention relates to a method of operating acompact, high aspect ratio auto-injector auto-injector for delivering amedicament dose subcutaneously or intramuscularly. The auto-injector caninclude a housing, a medicament dispensing system including a medicamentreservoir adapted to contain the dose, and a needle extension mechanismcoupled to the medicament reservoir, the needle extension mechanismincluding a curved injection needle. The method can include the steps oftriggering deployment of a distal end of a curved injection needlethrough an aperture in a cover of the housing to straighten theinjection needle; triggering piercing of the medicament reservoir toprovide fluidic communication between the reservoir and the curvedinjection needle; dispensing the dose through the injection needle at adesired injection location; and thereafter, retracting the distal end ofthe injection needle into the auto-injector.

In some embodiments of the above aspect, the auto-injector furtherincludes an interlock, such that the housing cannot be rotated relativeto the cover or displaced axially relative to the cover without removalof the interlock. In some cases the housing can include a sealed housingrotatably retained in the cover and the method further includes manuallyrotating the housing relative to the cover from a first locked positionto a second unlocked position, in which the sealed housing isautomatically displaced axially relative to the cover to an armedposition, increasing a height of the auto-injector. In some instances,the method further includes the step of determining the locked position,the unlocked position, and the armed position based on indicia on atleast one of the housing, the cover, a label, and a component directlyvisible to the user. The method can further include adhering the coverto the desired injection location prior to triggering of theauto-injector. In some instances, the step of triggering piercing of themedicament reservoir includes manually compressing the auto-injectorwhen the auto-injector is in the armed position, which includesactivating the medicament dispensing mechanism triggering piercing of aplunger within the medicament reservoir with a distal end of adispensing needle. The step of triggering piercing of the medicamentreservoir can further include pumping the dose out of the reservoir tothe injection needle.

In some embodiments of the above aspect, the step of manuallycompressing the auto-injector when the auto-injector is in the armedposition further includes activating the needle extension mechanismtriggering the deployment of the curved injection needle through theaperture in the cover. In some cases, the step of activating the needleextension mechanism including deploying the curved injection needlethrough the aperture in the cover further includes rotating a needlebarrel to drive the distal end of the curved injection needle throughthe aperture. In some cases, the step of activating the needle extensionmechanism includes deploying a distal end of the curved injection needlethrough the aperture in the cover to straighten the injection needle.The step of retracting the distal end of the injection needle into theauto-injector can result from releasing manual compression of theauto-injector. The method can also include the step of removing theauto-injector from the desired injection location after dispensing thedose. The method can also include the step of automatically interlockingthe auto-injector after retraction of the needle to prevent reuse of theauto-injector and exposure of a distal end of the injection needle. Themethod can also include the step of disposing of the auto-injector aftera single use.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, reference characters generally refer to the same partsthroughout the different views. Also, the drawings are not necessarilyto scale, emphasis is instead generally being placed upon illustratingthe principles of the invention. In the following description, variousembodiments of the present invention are described with reference to thefollowing drawings, in which:

FIG. 1 is a comparison of existing auto-injector form factor aspectratios versus an example high aspect ratio auto-injector, according tovarious embodiments;

FIG. 2 is a depiction of the injection sequence indicating a user'sinputted actions with the auto-injector and the subsequent auto-injectoroutputs, according to various embodiments;

FIG. 3 is a schematic isometric view of an auto-injector in the storedor locked position, according to various embodiments;

FIG. 4 is a schematic side view of the auto-injector in the stored orlocked position, according to various embodiments;

FIG. 5 is a schematic isometric exploded view of internals of theauto-injector, according to various embodiments;

FIG. 6 is a schematic side exploded view of internals of theauto-injector, according to various embodiments;

FIGS. 7-11 are schematic side view of the sequential steps in performingan injection, according to various embodiments (e.g., depicted in FIG.2);

FIGS. 12-140 are schematic views of various system assemblies andcomponents of auto-injectors, according to various embodiments; and

FIG. 141 is a chart listing exemplary value ranges for certainparameters of the auto-injector, according to various embodiments.

DETAILED DESCRIPTION

A first embodiment of an auto-injector 1 is described below. Exampleuser interactions and inputs with the auto-injector 1 are describedfirst, followed by example internal mechanisms and interactions of theauto-injector's 1 components.

To assist the user in performing a proper administration, theauto-injector 1 should be correctly oriented at the time of injection.The auto-injector 1 may assist orientation with labeling, tactilesurfaces, material color or transparency, and/or other indiciaindicating select sides. Furthermore, the auto-injector 1 may presentitself with rotational aids MC-301 (see, e.g., FIG. 29), which can becontoured, textured, coated (or combinations thereof) such to furtherindicate orientation and operation. In addition, the auto-injector 1 caninclude a viewing window into the internals of the auto-injector 1 formedicament inspection which may further assist the user in establishingproper orientation.

In certain embodiments, the auto-injector 1 includes a safety mechanismSS-200 (see, e.g., FIGS. 3-7) to be initially removed before anysubsequent operations. An injection surface MC-121 (see, e.g., FIG. 17)may be exposed to the user once the safety mechanism SS-200 has beenremoved, further aiding in establishing a proper orientation. The safetymechanism SS-200 may also provide a means of preventing the sealedhousing MC-200, MC-300 (see, e.g., FIGS. 3-6) from displacing relativeto the cover MC-100 (see, e.g., FIGS. 3-6) prior to removal, such thatthe injection sequence may not commence without first removing saidmechanism SS-200. Alternatively, or additionally, the safety mechanismSS-200 may protect the user from an injection needle NES-700 (see, e.g.,FIG. 65) if an accidental discharge were to happen or remove aprotective shroud or sheath NES-100 (see, e.g., FIG. 38-40) thatperforms a similar functionality. Therefore, the removal of the safetymechanism SS-200 may provide or facilitate the followingfunctionalities: establish orientation of the auto-injector 1, providean interlock SS-204 (see, e.g., FIGS. 101-102) to prevent thedisplacement of the sealed housing MC-200, MC-300 relative to the coverMC-100 prior to removal, protecting the user from the injection needleNES-700, removing a conjoined or coupled component NES-100 that wouldfurther protect the injection needle NES-700 or user from said injectionneedle NES-700, as well as protecting a tactile coating or surface onthe injection contact surface MC-121 (see, e.g., FIG. 17) of the coverMC-100.

In various embodiments, in addition to the internal components discussedbelow, the auto-injector 1 includes two main parts, a sealed housingMC-200, MC-300 rotatably retained in a cup-shaped cover MC-100 that alsoforms the bottom side or injection contact surface MC-121. The sealedhousing MC-200, MC-300 is made from upper MC-300 and lower MC-200 halvesbonded together through the means of ultrasonic welding or alternativemeans that provide sufficient adhesion and strength. In some embodimentsthe bond between the upper MC-300 and lower MC-200 halves may be suchthat it is a hermetic seal. Furthermore, the housing MC-200, MC-300 orone of the subsequent halves that compose the housing MC-200, MC-300 maycontain tabs MC-210 (see, e.g., FIG. 12), that are molded or formedprotrusions that guide and constrain the housing MC-200, MC-300 duringoperation within the cover MC-100. The sealed housing MC-200, MC-300functions as the primary interface for the user performing thesubsequent injection. The two halves that form the sealed housing, areof such geometry (e.g.: MC-201, MC-202, MC-204, MC-205, MC-206, MC-207,MC-208, MC-211, MC-213, MC-214, MC-216, MC-217, MC-218, MC-304, MC-305,MC-309, MC-310, MC-311, MC-312, MC-313, MC-314, MC-316) that they maylocate and secure the internal components.

The cover MC-100, provides a protective shroud around the housingMC-200, MC-300 and supports the housing for rotation. In someembodiments, the first step in performing or initiating an injection isto remove the safety mechanism SS-200. The next step can be to place theinjection contact surface MC-121 of the cover MC-100 on location. Asmentioned previously, the safety mechanism SS-200 may aid the user inestablishing an overall orientation of the auto-injector 1; therefore,once the injection contact surface MC-121 of the cover MC-100 is exposedfrom its removal it may further establish this orientation. Theinjection contact surface MC-121 of the cover MC-100 may provide atactile surface which can facilitate the following functionalities:provide a stabilizing base for the auto-injector 1 during injection, aidthe user in establishing orientation, and/or affix the auto-injector 1to the injection location through the means of an adhesive or otherattachment means.

In various embodiments, the cover MC-100 has a spring SS-300 (see, e.g.,FIGS. 5-6) disposed or formed therein, to bias the housing MC-200,MC-300 away from the cover MC-100 during activation, to facilitate use.A sidewall of the cover MC-100 may include channels, slots, detents,etc. MC-103 (see, e.g., FIG. 15) that correspond to different positionsMC-117, MC-118, MC-119, MC-120 (see FIG. 18) or positions (e.g., locked,unlocked, armed, and injection) that cooperate with tabs or protrusionsMC-210 (see FIGS. 21-22) on a sidewall of the housing MC-200, MC-300 orsuch components that form the housing MC-200, MC-300, to maintainalignment and control relative movement between various positions (e.g.,locked, unlocked, armed, and injection). The channels, slots, detents,etc. MC-103 formed in the cover MC-100 guide the housing MC-200, MC-300during the twisting, expanding, compressing, and subsequent expanding ofthe auto-injector 1 to facilitate the different phases of the injectionmethod and use. In addition, the cover MC-100 facilitates the means ofactivating an interlock SS-100 (see, e.g., FIGS. 11-14) such that oncethe cover MC100 is in an injection position MC-120 and injection hascommenced, subsequent expansion of the housing MC-200, MC-300 relativeto the cover MC-100 has occurred, the auto-injector 1 may not becompressed a second time rendering the auto-injector 1 single use. Thetriggering mechanism MC-109 (see, e.g., FIGS. 19-20) is designed suchthat the interlock SS-100 will always be activated before the MDS or theNES to ensure that the sharps injury prevention feature functions, ifthe injection needle NES-700 is ever deployed. The cover MC-100 may alsocontain geometry MC-101, MC-102 or indicia, formed, molded or stamped toprovide an orientation of the housing MC-200, MC-300 for either assemblyof the auto-injector 1 or for operational administration.

In various embodiments, when the auto-injector 1 is in a stored positionMC-117 and prior to use, the auto-injector 1 is in a locked position, inwhich the spring SS-300 is compressed and the auto-injector 1 isconstrained. To move from the locked position MC-117 to the unlockedposition MC-118, the user manually rotates the housing MC-200, MC-300 byapplying an activation force to the grip surfaces MC-301 (e.g., one ormore depressions, protrusions, textures, coatings, or combinations,etc.) formed on the upper surface MC-300 of the housing MC-200, MC-300.The user applied force displaces the sealed housing MC-200, MC-300relative to the cover MC-100 from the locked position MC-117 to theunlocked position MC-118. Indicia, such as alignment marks on thesidewalls of the housing MC-200, MC-300 and the cover MC-100 mayindicate the different positions (MC-117, MC-118, MC-119, MC-120) of theauto-injector 1. The alignment indicia may also be indicated usinglabels or other auto-injector 1 components (e.g., interlock SS-100) thatare observable from the exterior surfaces. Once the housing MC-200,MC-300 is rotated from the locked position MC-117 to the unlockedposition MC-118, the housing MC-200, MC-300 is biased away from thecover MC-100, and the auto-injector 1 expands to the armed positionMC-119. The expansion from the unlocked position MC-118 to the armedposition MC-119 is performed automatically by means of the storedpotential energy in the biasing member SS-300, such that the user onlyneeds to apply an activating force to the grip surfaces MC-301 to movethe auto-injector 1 from the locked position MC-117 to the unlockedposition MC-118. The automatic translation and rotation of the sealedhousing MC-200, MC-300 relative to the cover MC-100 may be constrainedand guided by the tabs or protrusions MC-210 on the sealed housingMC-200, MC-300 and channels, slots, detents, etc. MC-103 on the coverMC-100.

In various embodiments, once the housing MC-200, MC-300 is in the armedposition MC-119, the tabs or protrusions MC-210 on the housing MC-200,MC-300, and the guides on the cover wall MC-103 prevent the housingMC-200, MC-300 from being rotated back to the unlocked position MC-118and the locked position MC-117. In the armed position MC-119, theauto-injector 1 can only be vertically displaced towards the injectionposition MC-120. The orientation of the auto-injector 1 is such that thetop side MC-300 is facing upwards (i.e., away from the injectionlocation), with the flat bottom surface MC-121 of the cover MC-100against the injection site. To inject the medicament, the user applies anormal force, perpendicular to the top side MC-300 pushing the sealedhousing MC-200, MC-300 into the cover MC-100 to commence the activationsequence of the auto-injector 1 and injection of the medicament. Theinterlock mechanism SS-100 is activated just before the auto-injector 1reaches the injection position MC-120, such that, once the user releasespressure, the interlock SS-100 is engaged, and a second injection cannotbe attempted. To ensure complete dosing, the user maintains force on thesealed housing MC-200, MC-300 to maintain the injection position MC-120for an allotted duration, and then releases pressure on the top sideMC-300 of the auto-injector 1. The release of pressure on the sealedhousing MC-200, MC-300 may permit the sealed housing MC-200, MC-300 totranslate relative to the cover MC-100, by means of the biasing memberSS-300, thereby retracting the needle NES-700. In various embodiments,since the interlocks SS-100 were previously activated MC-109, they willengage themselves while the sealed housing MC-200, MC-300 is translatingrelative to the cover MC-100. After the injection has been performed andthe interlock SS-100 has engaged the triggering mechanism MC-109, aforce of, at minimum, twice the injection force on the sealed housingMC-200, MC-300 will not permit exposure of the needle NES-700 from theinjection contact surface MC-121of the cover MC-100 and is able to besafely disposed of.

The following list of items (1-11) describes an example activationsequence of internal components and mechanisms of the auto-injector 1and the individual component interactions, according to variousembodiments.

1.) Before initiating an injection, the user can remove a safetymechanism SS-200 before any subsequent operations. The safety mechanismSS-200 protects the injection surface MC-121 such that upon removal, theinjection surface MC-121 is exposed to the user, which may further aidin establishing proper orientation. The safety mechanism SS-200 can alsoprovide a means (e.g., interlock SS-204) of preventing the sealedhousing MC-200, MC-300 from displacing relative to the cover MC-100prior to removal, such that the injection sequence may not commencewithout first removing said mechanism SS-200. The safety mechanismSS-200 may also remove a needle sheath NES-100 that protects the userfrom the injection needle NES-700 in the event of an accidentaldischarge. Additionally, the sheath NES-100 in combination with abarrier NES-600 (see, e.g., FIGS. 38-40) can cover the injection needleNES-700 and may prevent any possible contamination during storage of theinjection needle NES-700. Therefore, at the time of injection, prior tothe removal of the needle sheath NES-100, the injection needle NES-700is sterile.

2.) Following the removal of the safety mechanism SS-200, the user canrotate the sealed housing MC-200, MC-300 from the locked position MC-117to the unlocked position MC-118, whereupon the sealed housing MC-200,MC-300 is automatically moved to the armed position MC-119 by a biasingmember SS-300. As a result, the housing MC-200, MC-300 translates androtates a certain constrained distance and angle. When the user appliesa force and transitions the sealed housing MC-200, MC-300 from the armedposition MC-119 to the injection position MC-120, the mechanisms thatinitiate the internal activation sequences inside the sealed housingMC-200, MC-300 are triggers or protrusions MC-106, MC-107 (see, e.g.,FIGS. 15-16). The activation triggers or protrusions MC-106, MC-107 canbe molded or formed on a surface of the cover MC-100. Cavities MC-202(see, e.g., FIGS. 22-23) are molded or formed into the lower half MC-200of the sealed housing MC-200, MC-300 to allow the sealed housing MC-200,MC-300 and the cover MC-100 to rotate and translate relative to oneanother without interfering with or damaging the activation mechanismMC-106, MC-107 or alignment mechanism MC-105 (see, e.g., FIGS. 19-20).During the assembly, activation, and injection, the protrusions or tabsMC-210, molded or formed on the sealed housing MC-200, MC-300 andcorresponding channels, slots, detents, etc. MC-103 on the cover MC-100,may interface to provide sufficient clearance and alignment to preventdamage of the protrusions or triggers on the cover MC-105, MC-106,MC-107. The cover MC-100 may also have alignment posts or protrusionsMC-105, that interface with corresponding cavities MC-211 (see, e.g.,FIG. 23) in the sealed housing MC-200, MC-300 at the time of injection(e.g., when the auto-injector 1 is in position MC-120) such that theymay aid in the alignment of the sealed housing MC-200, MC-300 and coverMC-100 to orient the triggers MC-106, MC-107 on the cover MC-100 withthe corresponding locking mechanisms NES-500 (see, e.g., FIGS. 38-41),MDS-100 (see, e.g., FIGS. 69-73) disposed in the sealed housing MC-200,MC-300. In some embodiments, the cover MC-100 and/or sealed housingMC-200, MC-300 may contain additional features (e.g., MC-103, MC-104,MC-109, MC-115, MC-210, SS-102) that aid in maintaining alignmentbetween the sealed housing MC-200, MC-300 and the cover MC-100 duringrelative movement.

3.) When the user applies a force to the top surface MC-300 of thesealed housing MC-200, MC-300 to compresses the sealed housing MC-200,MC-300 into the cover MC-100 to perform the injection, the first systemto be activated may be the interlock system SS-100. Activating theinterlock system SS-100 first, ensures that when the user deploys theneedle extension system (NES), the interlock system SS-100 will alwaysengage the triggering mechanism MC-109. In some embodiments, theinterlocks SS-100 are activated by an interference fit between the coverMC-109 and interlock SS-101 (see, e.g., FIGS. 98-100) when the sealedhousing MC-200, MC-300 is compressed during injection. Following theinjection, and the release of pressure on the sealed housing MC-200,MC-300, the sealed housing MC-200, MC-300 may be automatically displacedrelative to the cover MC-100, and the interlocks SS-100 are deployed orengaged. Prior to activation, the interlocks SS-100 can be held in astored state in cavities MC-201 (see, e.g., FIG. 103), MC-314 (see,e.g., 29-34) in the sealed housing MC-200, MC-300.

4.) Following the activation of the interlocks SS-100, the needleextension system (NES) can be activated. The corresponding needleextension trigger or protrusion MC-107 on the cover MC-100 breaks theplane of the sealed housing MC-200, MC-300 in a predetermined locationMC-203 (see, e.g., FIG. 23) and contacts the fixture or lockingmechanism NES-500 of the NES. The fixture or locking mechanism NES-500of the NES can preserve the potential energy of a biasing member NES-800(see, e.g., FIGS. 67-68). The biasing member NES-800 may be coupled tothe needle barrel NES-200 (see, e.g., FIGS. 46-50) at a specifiedcontact point NES-202 (see, e.g., 48-50). In one embodiment the biasingmember NES-800 is a torsion spring which rotates the needle barrelNES-200. The fixture or locking mechanism NES-500 may maintain thepotential energy of the torsion spring NES-800 by an interferenceportion NES-201 (see, e.g., FIG. 47) with the needle barrel NES-200. Thecontact portion NES-501 (see, e.g., FIGS. 60-62) between the needleextension trigger or protrusion MC-107 on the cover MC-100 and thefixture or locking mechanism NES-500 disengages the locking mechanismNES-500, releasing the potential energy stored in the torsion springNES-800. The release of the torsion spring NES-800 rotates the needlebarrel NES-200 and deploys the curved injection needle NES-700. Thehousing may have an internal geometric portion MC-307 (see, e.g., FIG.31) to facilitate the disengagement of the locking mechanism NES-500 atthe time of injection.

5.) Once the locking mechanism NES-500 is disengaged from the needlebarrel NES-200, the torsion spring NES-800 may rotate the needle barrelNES-200. The injection needle NES-700 may be fixed to and retained inthe needle barrel NES-200 by a needle barrel cap NES-300 (see, e.g.,FIGS. 51-54) that mates element NES-308 (see, e.g., FIGS. 53-54) with acorresponding recess NES-207 formed in the needle barrel NES-200. Theneedle barrel cap NES-300 may secure the injection needle NES-700 to theneedle barrel NES-200 through a friction fit between elements NES-306(see, e.g., FIGS. 53-54), NES-206 (see, e.g., FIGS. 46-47). In addition,the barrel cap NES-300 may secure a flexible tubing NES-900 (see FIG.40) to the injection needle NES-700 through a friction or compressionfitting formed by elements NES-304 (see FIG. 51), NES-305 (see FIG. 51),NES-204 (see FIG. 49), NES-205 (see FIG. 49). Furthermore, the needlebarrel cap NES-300 provides a contact surface NES-301 (see FIG. 52) forlimiting the needle barrel's NES-200 rotation to a specific angle. Invarious embodiments, the bottom half MC-200 of the sealed housingMC-200, MC-300 provides an interface MC-218 (see, e.g., FIGS. 21-22)which contacts the needle barrel cap NES-300 during rotation to limitthe angular displacement of the barrel NES-200 to the desired rotationangle, proportional to the desired injection depth. The barrel capNES-300 and the bottom half MC-200 of the sealed housing MC-200, MC-300work together to prevent the injection needle NES-700 from over rotatingand ensure that the proper injection depth is achieved. The needlebarrel NES-200 maintains alignment along its rotational axis duringrotation through guides (e.g., NES-203 (see FIG. 46), NES-303 (see FIG.51), NES-208 (see FIG. 48)) formed in the sealed housing MC-200, MC-300halves (e.g., MC-207, MC-312, MC-316, MC-302, MC-310, MC-309, MC-216) aswell as a needle barrel guide NES-400 (see FIGS. 55-59). These guidesmay maintain axial alignment and prevent the needle barrel NES-200 andinjection needle NES-700 from translating relative to the sealed housingMC-200, MC-300 during injection. The needle barrel guide NES-400 mayalso provide a channel NES-401 (see FIG. 55) to brace and guide the NESlocking mechanism NES-500 (see, e.g., FIGS. 60-62) during auto-injector1 storage and injection. In some embodiments the needle barrel capNES-300 can be ultrasonically welded (see welds NES-210 (FIG. 49),NES-307(FIG. 51) or utilize another means of joining the two componentstogether. Additionally, the NES components of the system can beintegrated independent of the housing MC-200, MC-300, during assembly.

6.) Upon rotation of the injection needle NES-700, the distal endNES-701 (see FIGS. 65-66) of the curved injection needle passes throughan aperture MC-204 (see FIG. 23) formed in the lower half MC-200 of thesealed housing MC-200, MC-300 and makes contact with a needle guideMC-110 (see FIG. 19) on the cover MC-100, such that a portion of thecurved injection needle NES-700 is straightened during uncoiling. Thelocation where the injection needle NES-700 contacts the surface MC-112,MC-113 (see FIG. 19) on the needle guide MC-110 may be such that thedistal end NES-701 (e.g., a lancet) is not in contact with the guideMC-110 to mitigate the chance of scoring or scraping the needle guideMC-110, and to mitigate the chance of producing debris. In addition tothe needle guide MC-110, the sealed housing MC-200, MC-300 may provide abrace MC-309 (see FIGS. 31-34) to further limit possible radial (withrespect to the needle axis) deflections during injection.

7.) After the needle barrel locking mechanism NES-500 has beendisengaged by the first trigger MC-107, further compression of thehousing MC-200, MC-300 into the cover MC-100, allows the second triggerMC-106 to initiate release of the medicament dispensing system (MDS) anddeliver the medicament. Similar to the NES, the medicament dispensingtrigger MC-106 makes contact MDS-101 with a corresponding fixture orlocking mechanism MDS-100 and releases said locking mechanism MDS-100.The trigger MC-106 makes contact at an interface portion MDS-101 (seeFIG. 74) when the fixture or locking mechanism MDS-100 is in apredetermined location MC-203. The fixture or locking mechanism MDS-100maintains the stored potential energy of a biasing member MDS-700 (seeFIG. 72). In one embodiment, the biasing member MDS-700 is a compressionspring that is bounded by a retainer MDS-400, MDS-300 (see FIGS. 72-73)and a keeper MDS-200 (see FIGS. 72-73). The release of the fixture orlocking mechanism MDS-100 allows the retainer MDS-300, MDS-400 todisplace relative to the keeper MDS-200 to make contact with a plungerMDS-900 (see FIG. 72). After contacting the plunger MDS-900, theretainer MDS-300, MDS-400 and plunger MDS-900 displace together. Thetotal displacement of the retainer MDS-300, MDS-400, and concomitantlythe plunger MDS-900, is determined by the keeper MDS-200 which mayprovide an interference or another feature MDS-201 (see FIGS. 78-80),MDS-309 (see FIGS. 81-84), MDS-409 (see FIGS. 85-88) to restrict theretainer's MDS-300, MDS-400 movement. As such, the displacement of theretainer MDS-300, MDS-400 relative to the keeper MDS-200 can beproportional to the amount of medicament expelled from the reservoirMDS-800 (see FIGS. 94-95). Furthermore, the housing MC-200, MC-300 mayhave sufficient internal geometry MC-306 (see FIG. 31) to assist in thedisengagement of the fixture or locking mechanism MDS-100 duringinjection.

8.) Upon release of the MDS fixture or locking mechanism MDS-100 (seeFIG. 74), the retainer MDS-300, MDS-400 can be displaced due to thestored potential energy of the compression spring MDS-700 and contactplunger MDS-900. A dispensing needle MDS-600 can be coupled to theretainer MDS-300, MDS-400 and in fluidic contact with the injectionneedle NES-700 through a flexible tubing NES-900. Furthermore, thedispensing needle MDS-600 like the injection needle NES-700 is protectedwith a protective barrier MDS-500 to prevent any contamination prior toinjection MC-120. Therefore, the release of the compression springMDS-700 causes the retainer MDS-300, MDS-400 to contact the plungerMDS-900, forcing the dispensing needle MDS-600 to pierce both theprotective barrier MDS-500 and the plunger MDS-900. The medicament isdispensed from the reservoir MDS-800 out of the dispensing needleMDS-600 (see FIG. 91) in the opposite direction of the movement of theplunger MDS-900. In various embodiments, the retainer MDS-300, MDS-400is composed of two halves (e.g., MDS-300, MDS-400) that areultrasonically welded (e.g., with welds MDS-405, MDS-305 (see FIGS.84,85)) together or by an alternative means that provides sufficientadhesion and strength. The retainer halves MDS-300, MDS-400 may securethe dispensing needle MDS-600 through a friction fit (MDS-602, MDS-302,MDS-402 (see FIGS. 82, 84, 91)). In addition, the retainer halvesMDS-300, MDS-400 may secure the flexible tubing NES-900 to thedispensing needle MDS-600 through a friction or compression fittingMDS-303, MDS-304, MDS-403, MDS-404 (see FIGS. 83-85) to prevent anypossible disengagement during dispensing. When fitted together, eachhalf of the retainer MDS-300, MDS-400 may have orienting featuresMDS-301, MDS-401 (see FIGS. 83-85) that force the proper alignment ofthe two halves MDS-300, MDS-400 during assembly, which also act tomaintain the dispensing needle MDS-600 and tubing NES-900 in properalignment. To maintain a sealed reservoir MDS-800 and to not contaminatethe medicament, the dispensing needle MDS-600 may only penetrate theprotective barrier MDS-500 (see FIGS. 89-90) and plunger MDS-900 at thetime of injection.

9.) Both the needle extension and drug dispensing triggers MC-106,MC-107, which activate the NES and MDS respectively, may havecomplimentary contoured surfaces to their respective locking mechanismsNES-501 (see FIGS. 60-62), MDS-101 (see FIG. 74) at the point of contactto reduce the force required to disengage and limit the induced stressesin the triggers MC-106, MC-107. Additionally, via the predeterminedinteraction location MC-203, the housings MC-200, MC-300 may providebracing MC-219 (see FIG. 26) to limit any possible deflections in thetriggers MC-106, MC-107, induced by the disengagement forces.

10.) The proximal end MDS-604 (see FIG. 91) of the dispensing needleMDS-600 may be fluidically connected to a proximal end NES-703 (see FIG.65) of the injection needle NES-700 by a length of flexible hose ortubing NES-900. The timing of the activation of the NES and MDS can besuch that the injection needle NES-700 is embedded into tissue and thedrug is dispensed within a designated, or predetermined time frame.

11.) After the injection, and the release of pressure on the sealedhousing MC-200, MC-300 by the user, the sealed housing MC-200, MC-300may automatically translate relative to the cover MC-100 due to thebiasing member SS-300. In some embodiments, the biasing member is acompression spring SS-300. During the subsequent expansion of the sealedhousing MC-200, MC-300 the interlocks SS-100 are removed from theircavities MC-201, MC-314 and restrict any relative motion between thesealed housing MC-200, MC-300 and cover MC-100. The interlocks SS-100prevent the auto-injector 1 from being collapsed, thereby preventingsubsequent extension of the distal end NES-701 of the injection needleNES-700 from the cover MC-100. The expansion of the sealed housingMC-200, MC-300 relative to cover MC-100 can be sufficient to fullywithdraw and conceal the injection needle NES-700 in the auto-injector1. Additionally, the channels, slots, detents, etc. MC-103 in the coverMC-100 and the molded or formed tabs or protrusions MC-210 on the sealedhousing MC-200, MC-300 may prevent any rotation of either the coverMC-100 or the sealed housing MC-200, MC-300 relative to one another. Theinterlocks SS-100 which prevent subsequent collapse of the auto-injector1 and the inability to rotate the cover MC-100 or housing MC-200, MC-300allow for a safe means of disposal, preventing accidental needleexposure NES-700.

The following paragraphs describe another embodiment of theauto-injector 1, including alternate or complimentary configurations andactivation sequences of the auto-injector 1.

In this embodiment, the auto-injector 1 may have an internal powersource to allow certain functionalities of the auto-injector 1 duringstorage, during injection, and post injection. The auto-injector 1 mayprovide audible instructions for performing an injection. Additionally,connectivity of the auto-injector 1 to everyday smart devices allows foradditional functionality. The connected smart device may display visualand/or auditory instructions for performing an injection. Certainembodiments may allow for the user to monitor the temperature, andlocation of the auto-injector 1. Additionally, the connected device mayallow the user to see if other auto-injectors 1 are nearby. Additionalembodiments may allow the smart device to contact emergency respondersor next of kin once an injection has been initiated. Furthermore,information about the auto-injector 1 may be monitored remotely by themanufacturer.

Similar to the embodiment described above, this embodiments canestablish an orientation of the auto-injector 1 prior to performing anyinjection, through proper human factor engineering principles. Theauto-injector 1 may present the user with an intuitive interface,leveraging existing mental models from everyday applications. In regardto the user interface, additional or alternative embodiments willprovide the same benefits with possible variations of the followingaspects: geometry or element 1101 (see FIG. 115), tactile surfaces,indicia, labeling, and/or coloring, that may aid the user inestablishing an orientation prior to performing an injection.

In certain embodiments, the auto-injector 1 includes a safety mechanismSS-200 to be removed before any subsequent operations. The injectionsurface MC-121 may be exposed to the user once the safety mechanismSS-200 has been removed, further aiding in establishing the properorientation. The safety mechanism SS-200 may also provide a means ofpreventing the auto-injector 1 from moving from a locked position 3102(see FIGS. 110-111) to an unlocked position 3103, 3104 (see FIGS.110-111) prior to removal, such that the injection sequence may notcommence without first removing the safety mechanism SS-200.Alternatively, or additionally, the safety mechanism SS-200 may protectthe user from an injection needle 4102 (see FIG. 122) if an accidentaldischarge were to happen, or remove a protective shroud or sheathNES-100 that can facilitate similar functionality. Therefore, theremoval of the safety mechanism SS-200 may provide or facilitate thefollowing functionalities, for example: establish orientation of theauto-injector 1, provide an interlock SS-204 to prevent rotation of thesealed housing prior to removal, protect the user from the injectionneedle 4102, remove a conjoined or coupled component NES-100 thatfurther protects the injection needle 4102 or a user from the injectionneedle 4102, and protect a tactile coating or surface on the injectioncontact surface MC-121 of a cover 3100 (see FIGS. 110-111).

In addition to the internal components discussed below, theauto-injector 1 can include two main parts, a sealed housing 1100, 2100(see FIGS. 105-107) rotatably retained in the cup-shaped cover 3100 thatmay also form the bottom side or injection contact surface MC-121. Thesealed housing can be made from upper half 1100 and lower half 2100bonded together through the means of ultrasonic welding or alternativemeans that provide sufficient adhesion and joint strength. In someembodiments the bond between the upper half 1100 and the lower half 2100may form a hermetic seal. In some cases, the housing 1100, 2100 or oneof the subsequent halves 1100, 2100 that compose the housing 1100, 2100contain molded or formed protrusions 2107 (see FIGS. 112-113) that guideand constrain the housing 1100, 2100 during operation within the cover3100. The sealed housing 1100, 2100 can function as the primaryinterface for the user performing the injection. In addition to thehousing 1100, 2100 being possibly hermetically sealed, the sealedhousing 1100, 2100 may contain additional sealing components MC-215 (seeFIG. 26), MC-315 (see FIGS. 31-32) or compounds to completely enclosethe internal chamber of the housing. This sealed chamber may perform thefollowing functionalities, for example: provide and maintain internaldesired cleanliness criteria, provide a water-resistant enclosure, andallow for a pressure differential between the internal and externalenvironments. Some embodiments of the auto-injector 1 may preserve thedesired internal conditions until the time of injection. The two halves1100, 2100 that form the sealed housing, can have a geometry and/orcomponents (e.g., 1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 2101,2102, 2103, 2104, 2105, 2106, 2108, 2109, 2110, 2112, 2113) that maylocate and secure the internal components.

The following list of items (1-14) describes another example activationsequence of internal components and mechanisms of the auto-injector 1and the individual component interactions, according to variousembodiments.

1.) When the user unlocks the housing 1100, 2100 from the cover 3100,the housing 1100, 2100 automatically moves to an armed position 3103(see FIGS. 110-111). The housing 1100, 2100 translates and rotates acertain constrained distance and degree. The mechanisms that activatethe internal activation sequences inside the sealed housing are triggersor protrusions MC-106, MC-107 which are molded or formed on a surface ofthe cover 3100. Cavities MC-202, MC-211 are molded or formed into thelower half 2100 of the sealed housing 1100, 2100 to allow the sealedhousing and the cover 2100 to rotate and translate relative to oneanother without interfering with or damaging the activation or alignmentmechanisms. During the assembly (see position 3105), activation (seepositions 3102, 3103), and injection (see position 3104), theprotrusions or tabs 2107, molded or formed on the sealed housing 1100,2100 and corresponding channels, slots, detents, etc. 3106, 3108, 3107(see FIG. 110) on the cover 3100, interface to provide sufficientclearance and alignment to prevent damage of the protrusions or triggersMC-106, MC-107 on the cover 3100. Furthermore, the cover 3100 can havealignment posts or protrusions MC-105, that interface with correspondingcavities MC-211 in the sealed housing 1100, 2100 at the time ofinjection such that they may aid in the alignment of the sealed housing1100, 2100 and cover 3100 to orient the triggers MC-106, MC-107 on thecover 3100 with the corresponding locking mechanisms 5100 (see FIG.136), 7110 (see FIG. 116) disposed in the sealed housing 1100, 2100.Additionally, the cover 3100 and/or sealed housing 1100, 2100 maycontain additional features that aid in maintaining alignment betweenthe sealed housing 1100, 2100 and the cover 3100 during relativemovement. The automatic expansion may occur due to a spring 3101 (seeFIGS. 108-111) disposed or formed therein, to bias the housing 1100,2100 away from the cover 3100 during activation, to facilitate use. Incertain embodiments the housing 1100, 2100 can be returned to the lockedposition 3102 and maintain the internal sealed nature of the sealedhousing. To return to the locked position 3103, 3104, the usercompresses the housing 1100, 2100 into the cover 3100 and rotates thehousing 1100, 2100 in the opposite direction.

2.) In certain embodiments the internal injection needle 4102 is notaligned with the needle aperture MC-112 formed in the bottom side of thecover 3100. Therefore, if the injection needle 4102 were toinadvertently misfire, the sharp distal end of the needle NES-701 wouldnot penetrate through the bottom side of the cover MC-121. The user mayverify the positioning of the housing 1100, 2100 relative to the cover3100 by means of indicia and labeling present on the auto-injector 1.

3.) Once the auto-injector 1 is in the unlocked position MC-118 and hastransitioned to the activated position 3103, 3104, the housing 1100,2100 can rotate freely without interference with the triggers MC-106,MC-107. Preceding the manual compression of the auto-injector 1 tofacilitate an injection, the housing 1100, 2100 can be reset or returnedto the locked position 3102, if accidental movement to the activatedposition 3103 has taken place.

4.) When the housing 1100, 2100 is compressed into the cover 3100,transitioning from the armed position 3104 to the injection positionMC-120, the triggers or protrusions MC-106, MC-107 on the cover 3100pierce the designated locations MC-203 on the housing 2100, makingcontact with the corresponding locks 5100, 7110, and starting theinjection sequence. To allow the triggers MC-106, MC-107 to penetratethrough the bottom side of the lower housing half 2100 without causingany loose breakage or compromising the structure of the triggers MC-106,MC-107. Therefore, the areas MC-203 where the triggers MC-106, MC-107penetrate may contain perforations or other aids MC-219 (e.g., differentmaterial, etc.).

5.) When the user compresses the auto-injector 1 to perform theinjection, the first trigger MC-107 pierces the lower housing half 2100and initiates the uncoiling of the curved injection needle 4102. Theuncoiling is initiated by the first trigger MC-107 disengaging thelocking mechanism 5100. The first trigger MC-107 pierces the housing andcontacts the uncoiling locking mechanism 5100. The uncoiling lockingmechanism 5100 is disengaged by being retracted from the needle barrel4100 (see FIGS. 125-130) where it sits during the stored, active, andarmed positions 3102, 3103, 3104. The housing 1100, 2100 may havesufficient internal geometry (see elements MC-306, MC-307 (see FIG. 31))to assist in the disengagement of the locking mechanisms 5100, 7110during the time of injection. Prior to engagement with the first triggerMC-307, the uncoiling of the injection needle 4102 may be prevented bythe uncoiling locking mechanism 5100, inhibiting the needle barrel 4100from rotating. Therefore, the corresponding torsion spring 8100 remainswound and under load. In this embodiment, a portion of the injectionneedle 4102 has a helical shape prior to injection and a straightenedout shape at the time of injection. The helical shape of the injectionneedle 4102 allows the auto-injector 1 to maintain a low profile andhigh aspect ratio. Additionally, the needle 4102 can be of such materialthat it will not be compromised during manufacturing or uncoiling duringinjection.

6.) Once the locking mechanism 5100 is disengaged from the needle barrel4100, the torsion spring 8100 is free to rotate the needle barrel 4100 aset angle. The injection needle 4102 can be fixed to a retainer 4103(see FIG. 122) that mates with a corresponding recess 4112 (see FIGS.125-126) formed in the needle barrel 4100. When the needle barrel 4100rotates, a portion of the helical injection needle 4102 is uncoiled. Inthis embodiment, a portion of the needle 4102 that was curved beforeinjection, can be straightened and embedded in tissue during theinjection. A pair of opposing ribs 2102 (see FIG. 108), 1104 (see FIGS.114-115) molded in the upper half 1100 and the lower half 2100 of thehousing keep the needle barrel 4100 in place and properly aligned duringrotation while both uncoiling and recoiling. In addition, the ribs orhousing 4113 (see FIGS. 125-126), 1104, 2102 that aligns and guides theneedle barrel 4100 may be formed or have such geometry (see elements1103 (see FIGS. 114-115), 2103 (see FIG. 112)) that guides and allowsthe injection needle 4102 to disengage from the needle barrel 4100.

7.) The distal end NES-701 of the helical injection needle 4102 passesthrough an aperture 2111 (see FIGS. 112-113) of similar size to theinjection needle 4102 formed in the lower housing half 2100, so that theinjection needle 4102 is straightened during uncoiling by the aperture2111. Controlling the needle barrel's 4100 rotation by an interferenceelement 4107 (see FIGS. 125-127) ensures the barrel 4100 is rotated thedesired predetermined number of degrees, ensuring that the distal endNES-701 of the needle 4102 is stopped at the desired injection depth.

8.) In addition, when the distal end NES-701 of the needle 4102 exitsthe lower housing half 2100, it may pass through and pierce a sealcovering the aperture 2111. The seal acts as the barrier between theinternals of the housing 1100, 2100 and the outside environment. Thisseal may by an adhesively adhered thin TPE membrane (e.g., Santoprene®material) that keeps the housing 1100, 2100 hermetically sealed. Inaddition, this type of seal allows the distal end NES-701 of the needle4102 to pass through, without removing any material, avoiding a corkingeffect and partial or complete blocking of the internal lumen or bore ofthe needle 4102 during injection. The seal may also ensure that thesterile internal environment of the housing is maintained.

9.) Once the needle barrel 4100 uncoiling rotation is complete, thetorsion spring 8100 can disengage from the needle barrel 4100. Thetorsion spring 8100 can disengage from the needle barrel 4100 because anuncoiling spring tensioner 4104 (see FIG. 128) which is in contact withboth the needle barrel 4100 and the torsion spring 8100 includes atorsion spring contact point 4106 (see FIG. 128) and collared surface4105 (see FIGS. 129-130) that has a noncircular shape. In oneembodiment, the torsion spring contact surface 4114 (see FIGS. 137-138)causes an axial deflection of the torsion spring 8100, due to thenon-circular collar 4105, allowing the proximal end 8103 (see FIG. 140)of the torsion spring 8100 to raise up and out of contact point 4106 onthe barrel 4100 and disengage from the needle barrel 4100. Disengagementcan occur, so that the recoil torsion spring 8101 that performs therecoiling of the injection needle 4102 onto the barrel 4100 does nothave to rewind the uncoiling torsion spring 8100.

10.) After the needle barrel locking mechanism 5100 has been disengagedby the first trigger MC-107, further compression of the housing 1100,2100 into the cover 3100 allows the second trigger MC-106 to initiatedispensing of the medicament. A plunger 7102 associated with a reservoiror vial 7100 containing the medicament is propelled or driven forward bya compression spring 7106, which in turn dispenses the medicament. Thecompression spring 7106 is actuated when the second trigger MC-106released a retainer 7101 that bounds and retains the spring 7106 in astored position. The compression spring 7106 drives the retainer 7101and in turn the plunger 7102 into the vial 7100, to force the medicamentout of the vial 7100, through the dispensing port 7104.

11.) The proximal end NES-703 of the injection needle 4102 isfluidically connected to the dispensing port 7104 by a length offlexible hose or tubing NES-900. The timing of the uncoiling NES andmedicament administration MDS is such that the injection NES andmedicament MDS delivery occur within a short designated time window(e.g., a few seconds after compression).

12.) Once the auto-injector 1 has been compressed against the injectionlocation and the injection has commenced, the individual holds theauto-injector 1 against the injection location for a designated timeduration. Upon release of the pressure on the auto-injector 1, after thedesignated time duration, recoiling of the injection needle 4102commences. Due to the biasing member 3101, the housing 1100, 2100automatically expands and upon expansion releases a third locking 9100(see FIGS. 133-134) mechanism which in turn activates the recoilingtorsion spring 8101 (see FIG. 129).

13.) While the auto-injector 1 is in the compressed configuration, therecoil torsion spring 8101 can be maintained in a wound state by anothertensioner 9101 (see FIGS. 131-132) and retainer 9100. This recoil springretainer 9100 may maintain the tensioned state of the recoil torsionspring 8101 during compression of the auto-injector 1 and injection ofthe dose. Note that the recoil spring 8101 may be disengaged from theneedle barrel 4100 during uncoiling of the injection needle 4102.Following the expansion, after injection, the recoil spring 8101 canengage interference element 4107 of the needle barrel 4100 such that theinjection needle 4102 is recoiled. This engagement 4107 of the recoilingspring 8101 on the needle barrel 4100 is facilitated by the axialmovement of the needle barrel 4100 during the uncoiling process. Toprevent the recoil torsion spring 8101 from unwinding (and recoiling theinjection needle 4102 prematurely) once the uncoiling spring 8100 isdisengaged from the needle barrel 4100, the trigger MC-106 actuates therecoil spring retainer 9100, such that full auto-injector 1 compressionacts as a temporary spring retainer, until the expansion of theauto-injector 1.

14.) Once the auto-injector 1 is permitted to expand after the injectionhas been completed, the trigger MC-106 disengages, releasing thetensioner 9101 and allowing the recoil torsion spring 8101 to recoil theinjection needle 4102 into the housing 1100, 2100. Subsequently aninterlock SS-100 prevents the injection needle 4102 from being able tobe deployed again.

The table below provides names and brief descriptions of the referencesnumerals appearing in the figures:

REFERENCE NUMERAL NAME DESCRIPTION MDS-100 RETAINER LOCKING COMPLETEPART MECHANISM MDS-101 RETAINER LOCKING TRIGGER CONTACT SURFACEMECHANISM MDS-102 RETAINER LOCKING LOCK DISENGAGMENT MECHANISM SURFACEFOR TH MDS-103 RETAINER LOCKING RETAINER CONTACT SURFACE MECHANISMMDS-104 RETAINER LOCKING RETAINER SHEATH CONTACT MECHANISM SURFACEMDS-200 RETAINER KEEPER COMPLETE PART MDS-201 RETAINER KEEPER RETAINERSTROKE HARD STOP MDS-202 RETAINER KEEPER RETAINER ALIGNMENT RAILSMDS-203 RETAINER KEEPER RESERVOIR ASSEMBLY TABS MDS-204 RETAINER KEEPERRETAINER LOCK CONTACT SURFACE MDS-300 RETAINER LEFT HALF COMPLETE PARTMDS-301 RETAINER LEFT HALF ASSEMBLY ALIGNMENT POST/HOLE MDS-302 RETAINERLEFT HALF DISPENSING NEEDLE CHANNEL MDS-303 RETAINER LEFT HALF FLEXIBLETUBING CHANNEL MDS-304 RETAINER LEFT HALF MOLDED FLEXIBLE TUBING CLAMPSMDS-305 RETAINER LEFT HALF U-SONIC WELD ENERGY DIRECTORS MDS-306RETAINER LEFT HALF RETAINER LOCK CONTACT SURFACE MDS-307 RETAINER LEFTHALF DISPENSING NEEDLE BARRIER LIP MDS-308 RETAINER LEFT HALF DISPENSINGSPRING SHOULDER MDS-309 RETAINER LEFT HALF RETAINER KEEPER STROKE STOPCONTACT SURFACE MDS-310 RETAINER LEFT HALF RETAINER TIP FOR PUSHING THEPLUNGER MDS-400 RETAINER RIGHT HALF COMPLETE PART MDS-401 RETAINER RIGHTHALF ASSEMBLY ALIGNMENT POST/HOLE MDS-402 RETAINER RIGHT HALF DISPENSNIGNEEDLE CHANNEL MDS-403 RETAINER RIGHT HALF FLEXIBLE TUBING CHANNELMDS-404 RETAINER RIGHT HALF MOLDED FLEXIBLE TUBING CLAMPS MDS-405RETAINER RIGHT HALF U-SONIC ENERGY DIRECTOR WELLS MDS-406 RETAINER RIGHTHALF RETAINER LOCK CONTACT SURFACE MDS-407 RETAINER RIGHT HALFDISPENSING NEEDLE BARRIER LIP MDS-408 RETAINER RIGHT HALF DISPENSINGSPRING SHOULDER MDS-409 RETAINER RIGHT HALF RETAINER KEEPER STROKE STOPCONTACT SURFACE MDS-410 RETAINER RIGHT HALF RETAINER TIP FOR PUSHING THEPLUNGER MDS-500 DISPENSING NEEDLE COMPLETE PART (CLEANLIESS) BARRIERMDS-501 DISPENSING NEEDLE PLUNGER FACING SURFACE (CLEANLIESS) BARRIERMDS-502 DISPENSING NEEDLE SEALING EDGE FOR RETAINER (CLEANLIESS) BARRIERMDS-600 DISPENSING NEEDLE COMPLETE PART MDS-601 DISPENSING NEEDLE LANCETTIP MDS-602 DISPENSING NEEDLE GRIT BLASTED SURFACE MDS-603 DISPENSINGNEEDLE HEEL DULLED AREA (TO PREVENT COREING) MDS-604 DISPENSING NEEDLEPROXIMAL END OF NEEDLE MDS-700 DISPENSING SPRING COMPLETE PART MDS-701DISPENSING SPRING RETAINER KEEPER CONTACT SURFACE MDS-702 DISPENSINGSPRING RETAINER SHOULDER CONTACT SURFACE MDS-800 MEDICAMENT RESERVOIRCOMPLETE PART MDS-900 PLUNGER COMPLETE PART MDS-901 PLUNGER TRIM EDGE(SEALING SURFACE) MDS-902 PLUNGER DISPENSING NEEDLE BARRIER CONTACTSURFACE NES-100 NEEDLE SHEATH COMPLETE PART NES-101 NEEDLE SHEATH SNAPFIT EDGE FOR SAFETY MECHANISM NES-102 NEEDLE SHEATH MOLD PIN SUPPORTWINDOWS NES-103 NEEDLE SHEATH INJECTION NEEDLE GUIDE CUT OUT ON SNAP FITEDGE NES-104 NEEDLE SHEATH TOP CURVED CUT OUT FOR FITTING UP TO THENEEDLE BARREL NES-200 NEEDLE BARREL COMPLETE PART NES-201 NEEDLE BARRELNEEDLE BARREL LOCK CUT OUT NES-202 NEEDLE BARREL TORSION SPRING SLOT CUTNES-203 NEEDLE BARREL FLEXIBLE TUBING CHANNEL CUT OUT (TO ALLOW FORTUBING DEFLECTION DURING ROTATION) NES-204 NEEDLE BARREL FLEXIBLE TUBINGCONTACT SURFACE WHILE BEING ULTRASONICALLY WELDED NES-205 NEEDLE BARRELMOLDED TUBING CLAMPS NES-206 NEEDLE BARREL INJECTION NEEDLE CHANNEL CUTOUT WITH TEXTURED SURFACE NES-207 NEEDLE BARREL NEEDLE BARREL CAP SHAFTRECEPTICAL NES-208 NEEDLE BARREL ROTATIONAL ALIGNMENT RIDGE FOR BARRELGUIDE CONTACT NES-209 NEEDLE BARREL INJECTION NEEDLE CHANNEL (COMPLETEDCHANNEL FORMED AFTER WELDING) NES-210 NEEDLE BARREL ULTRASONIC WELD STEPON NEEDLE BARREL FACE NES-300 NEEDLE BARREL CAP COMPLETE PART NES-301NEEDLE BARREL CAP HARD STOP CUT OUT NES-302 NEEDLE BARREL CAP TORSIONSPRING WINDING CUT OUT IN FACE OF NEEDLE BARREL CAP NES-303 NEEDLEBARREL CAP FLEXIBLE TUBING CHANNEL CUT OUT (TO ALLOW FOR TUBINGDEFLECTION DURING ROTATION) NES-304 NEEDLE BARREL CAP FLEXIBLE TUBINGCONTACT SURFACE WHILE BEING ULTRASONICALLY WELDED NES-305 NEEDLE BARRELCAP MOLDED TUBING CLAMPS NES-306 NEEDLE BARREL CAP INJECTION NEEDLECHANNEL CUT OUT WITH TEXTURED SURFACE NES-307 NEEDLE BARREL CAPULTRASONIC WELD ENERGY DIRECTOR NES-308 NEEDLE BARREL CAP NEEDLE BARRELCAP SHAFT NES-309 NEEDLE BARREL CAP INJECTION NEEDLE CHANNEL (COMPLETEDCHANNEL FORMED AFTER WELDING) NES-400 NEEDLE BARREL GUIDE COMPLETE PARTNES-401 NEEDLE BARREL GUIDE NEEDLE BARREL LOCK CHANNEL NES-402 NEEDLEBARREL GUIDE TORSION SPRING BRACE LEG CUT OUT NES-403 NEEDLE BARRELGUIDE NEEDLE BARREL TAIL ROTATION STABILIZING HOLE NES-404 NEEDLE BARRELGUIDE NEEDLE BARREL SHOULDER, FOR SETTING DEPTH OF NEEDLE BARREL IN THEGUIDE NES-500 NEEDEL BARREL LOCK COMPLETE PART NES-501 NEEDEL BARRELLOCK TRIGGER CONTACT SURFACE NES-502 NEEDEL BARREL LOCK LOCKDISENGAGEMENT SURFACE FOR THE TOP HALF NES-503 NEEDEL BARREL LOCKLOCKING DEPTH SHOULDER FOR THE NEEDLE BARREL GUIDE NES-504 NEEDEL BARRELLOCK NEEDLE BARREL CONTACT SURFACE NES-600 NEEDLE SHEATH COMPLETE PART(CLEANLIENESS) BARRIER NES-601 NEEDLE SHEATH MOLDED RIBBING FOR PRESS(CLEANLIENESS) BARRIER FITTING IN NEEDLE SHEATH NES-602 NEEDLE SHEATHTOP CURVED CUT OUT FOR (CLEANLIENESS) BARRIER FITTING UP TO THE NEEDLEBARREL NES-700 INJECTION NEEDLE COMPLETE PART NES-701 INJECTION NEEDLEDISTAL END/LANCET TIP NES-702 INJECTION NEEDLE GRIT BLASTED SURFACENES-703 INJECTION NEEDLE PROXIMAL END NES-800 TORSION SPRING COMPLETEPART NES-801 TORSION SPRING ROTATIONAL LEG MAKING CONTACT WITH THENEEDLE BARREL NES-802 TORSION SPRING BRACING LEG (SUPPORTED ON THENEEDLE BARREL GUIDE) NES-900 FLEXIBLE TUBING COMPLETE PART SS-100AUTO-INJECTOR COMPLETE PART INTERLOCK SS-101 AUTO-INJECTOR LOCKOUTENGAGMENT ARM INTERLOCK SS-102 AUTO-INJECTOR KICK BACK FOOT INTERLOCKSS-103 AUTO-INJECTOR SLANTED FOOT FOR LOCKOUT INTERLOCK SS-200 SAFETYMECHANISM COMPLETE PART SS-201 SAFETY MECHANISM TAPERED LEAD IN EDGE FORNEEDLE SHEATH SS-202 SAFETY MECHANISM ALIGNMENT PROTRUSIONS FOR ASSEMBLY(FIT IN GRABBER UNDECUTS) SS-203 SAFETY MECHANISM NEEDLE SHEATH HOLESS-204 SAFETY MECHANISM LOCKING POST SS-300 EXPANSION SPRING COMPLETEPART SS-301 EXPANSION SPRING CONTACT SURFACE FOR BOTTOM HALF SS-302EXPANSION SPRING CONTACT SURFACE FOR COVER MC-100 COVER COMPLETE PARTMC-101 COVER EXPANSION SLOTS FOR ASSEMBLY MC-102 COVER ASSEMBLYALIGNMENT CHANNELS FOR EXPANSION TABS ON THE BOTTOM HALF MC-103 COVERROTATIONAL CHANNEL FOR THE EXPANSION TABS ON THE BOTTOM HALF MC-104COVER EJECTOR PIN LOCATIONS MC-105 COVER ALIGNMENT POSTS FOR THE BOTTOMHALF DURING INJECTION MC-106 COVER RETAINER TRIGGER MC-107 COVER NEEDLEBARREL LOCK TRIGGER MC-108 COVER EXPANSION SPRING RECESS CUT MC-109COVER PUCK STOPPER GRABBER CONTACT SURFACE FOR THE STOPPER MC-110 COVERINJECTION NEEDLE GUIDE MC-111 COVER NEEDLE SHEATH HOLE MC-112 COVERINJECTION NEEDLE HOLE MC-113 COVER INJECTION NEEDLE GUIDE TAPEREDUNDERCUT TO PREVENT PLASTIC SCORING MC-114 COVER GRABBER UNDERCUT HOLEFOR THE SAFETY COVER PROTRUSIONS MC-115 COVER WALL CUT AWAY FOR STOPPERCLEARANCE MC-116 COVER PERIMETER WALL CUT TO PREVENT DEFORMATION DURINGMOLDING MC-117 COVER STORED/LOCKED POSITION MC-118 COVER UNLOCKEDPOSITION MC-119 COVER ARMED POSITION MC-120 COVER INJECTION POSITIONMC-121 COVER INJECTION SURFACE MC-200 BOTTOM HALF COMPLETE PART MC-201BOTTOM HALF HOUSINGS FOR PUCK STOPPERS MC-202 BOTTOM HALF HOUSINGS FORTRIGGERS AND ALIGNMENT POSTS (DURING STORED STATE) MC-203 BOTTOM HALFTRIGGER HOLES MC-204 BOTTOM HALF NEEDLE SHEATH HOLE MC-205 BOTTOM HALFRETAINER KEEPER RECESS CUT MC-206 BOTTOM HALF RESERVOIRCUT OUT/RESERVOIRCRADDLE MC-207 BOTTOM HALF NEEDLE BARREL CRADDLE MC-208 BOTTOMHALF RESERVOIRBRACING WALL MC-209 BOTTOM HALF ASSEMBLY FINS FOR TOP HALFMC-210 BOTTOM HALF ROTATION/EXPANSION TABS MC-211 BOTTOM HALF ALIGNMENTPOST HOUSINGS FOR INJECTION MC-212 BOTTOM HALF PUCK STOPPER LEDGE FORDEVICE LOCK OUT MC-213 BOTTOM HALF EXPANSION SPRING RECESS CUT OUTMC-214 BOTTOM HALF INJECTION NEEDLE GUIDE CUT OUT MC-215 BOTTOM HALFPUCK SEALING SURFACE WITH TEXTURED PROFILE MC-216 BOTTOM HALF NEEDLEBARREL GUIDE PLATFORM MC-217 BOTTOM HALF KEYED SLOT FOR SAFETY PLATEMC-218 BOTTOM HALF HARD STOP FOR NEEDLE BARREL ROTATION MC-219 BOTTOMHALF TIRGGER BRACING MC-300 TOP HALF COMPLETE PART MC-301 TOP HALFFINGER PLACEMENT LOCATIONS (FOR ROTATION) MC-302 TOP HALF RIDGE ON TOPSURFACE FOR NEEDLE BARREL GUIDE AND ROTATIONAL AID MC-303 TOP HALFASSEMBLY FIN CUT OUTS FOR BOTTOM HALF MC-304 TOP HALF RESERVOIRCUTOUT/CRADDLE FOR VIAL MC-305 TOP HALF CUT OUT FOR THE RETAINER KEEPERMC-306 TOP HALF RETAINER LOCK DISENGAGEMENT RAMP MC-307 TOP HALF NEEDLEBARREL LOCK DISENGAGEMENT RAMP MC-308 TOP HALF EJECTOR PIN LOCATION ONNEEDLE BRACE MC-309 TOP HALF INJECTION NEEDLE BRACE MC-310 TOP HALFFLEXIBLE TUBING CUT OUT FOR ROTATING AROUND THE NEEDLE BARREL MC-311 TOPHALF RESERVOIRBRACING WALL MC-312 TOP HALF NEEDLE BARREL LEDGE CUT(KEEPS THE NEEDLE BARREL INSIDE THE GUIDE DURING ROTATION BY PREVENTINGAXIAL DISPLACEMENT) MC-313 TOP HALF NEEDLE BARREL GUIDE CUT OUT MC-314TOP HALF PUCK STOPPER HOUSINGS MC-315 TOP HALF PUCK SEALING SURFACE/RIMMC-316 TOP HALF NEEDLE BARREL TAIL CUT OUT 1 AUTOINJECTOR ASSEMBLY FULLASSEMBLY INCLUDING THE COVER 1100 TOP HALF TOP HALF 1101 TOP HALF FINGERTAB 1102 TOP HALF ASSEMBLY ALIGNMENT HOLES 1103 TOP HALF MALE THREAD FORHELIX 1104 TOP HALF MIDDLE HOUSING 1105 TOP HALF RESERVOIRRECESS CUT TOPHALF 1106 TOP HALF RECOILING SPRING CUTOUT 1107 TOP HALFRESERVOIRCRADDLE HOUSING SIDE 1108 TOP HALF RESERVOIRCRADDLE OUTSIDEEDGE 1109 TOP HALF RETAINER GUIDE HOUSING 2100 BOTTOM HALF BOTTOM HALF2101 BOTTOM HALF ASSEMBLY ALIGNMENT PYRAMIDS 2102 BOTTOM HALF MIDDLEHOUSING 2103 BOTTOM HALF MALE THREAD FOR HELIX ALIGNMENT 2104 BOTTOMHALF RESERVOIRRECESS CUT BOTTOM HALF 2105 BOTTOM HALF RESERVOIRCRADDLEHOUSING SIDE 2106 BOTTOM HALF RESERVOIRCRADDLE OUTSIDE EDGE 2107 BOTTOMHALF EXPANSION TABS 2108 BOTTOM HALF RESERVOIRREAR BRACE BOTTOM HALF2109 BOTTOM HALF UNCOILING SPRING BRACE 2110 BOTTOM HALF HELIX LOCKGUIDE CHANNEL 2111 BOTTOM HALF INJECTION NEEDLE HOLE IN BOTTOM HALF 2112BOTTOM HALF RETAINER GUIDE HOUSING 2113 BOTTOM HALF RECOIL LOCKALIGNMENT SLOTS 3100 COVER COVER WITH MOLDED SPRINGS 3101 COVER MOLDEDSPRINGS 3102 COVER STORED/COLLAPSED CONFIGURATION POSITION 3103 COVERACTIVATED CONFIGURATION POSTION 3104 COVER ARMED CONFIGURATION POSITION3105 COVER ASSEMBLY SHOULDER IN COVER FOR REACHING STORED POSITION 3106COVER EXPANSION CHANNEL IN COVER 3107 COVER STORED/COLLAPSED POSITIONLOCK 3108 COVER ACTIVE TO ARMED LOCK 4100 NEEDLE BARREL HELIX 4101NEEDLE BARREL NEEDLE BARREL WITH SLANTED CHANNEL 4102 NEEDLE BARRELCOILED NEEDLE 4103 NEEDLE BARREL COILED NEEDLE COLLAR 4104 NEEDLE BARRELUNCOILING TENSIONER 4105 NEEDLE BARREL UNCOILING TENSIONER LOBED HEAD4106 NEEDLE BARREL UNCOILING TORSIONAL SPRING SLOT IN HELIX 4107 NEEDLEBARREL RECOILING SPRING SLOT IN HELIX 4108 NEEDLE BARREL NEEDLE BARRELWITH SLANT CUT TORSIONAL SPRING SLOT 4109 NEEDLE BARREL UNCOILINGTENSIONER SQUARE HOLE FOR WINDING 4110 NEEDLE BARREL SLANTED CHANNELNEEDLE BARREL THRUST BEARING 4111 NEEDLE BARREL SLANTED CHANNELINJECTION NEEDLE GUIDE CHANNEL 4112 NEEDLE BARREL NEEDLE COLLAR SLOT INHELIX 4113 NEEDLE BARREL NEEDLE GUIDE GROOVE IN HELIX 4114 NEEDLE BARRELUNCOILING TENSIONER TORSIONAL SPRING SLOT 5100 NEEDLE BARREL LOCK HELIXLOCK 5101 NEEDLE BARREL LOCK SLANTED CUT FOR TRIGGER 5102 NEEDLE BARRELLOCK SLANTED CUT HELIX SIDE 7100 MEDICAMENT RESERVOIR & VIAL ASSEMBLY7101 MEDICAMENT RESERVOIR & RETAINER ASSEMBLY 7102 MEDICAMENT RESERVOIR& PLUNGER ASSEMBLY 7103 MEDICAMENT RESERVOIR & SHEATH ASSEMBLY 7104MEDICAMENT RESERVOIR & RESERVOIR MOLDED IN 90 ASSEMBLY DEGREE ELBOW TIP7105 MEDICAMENT RESERVOIR & PLUNGER MOLDED RECEPTICLE ASSEMBLY FORRETAINER 7106 MEDICAMENT RESERVOIR & DISPENSING SPRING ASSEMBLY 7107MEDICAMENT RESERVOIR & RETAINER TIP FOR PLUNGER ASSEMBLY 7108 MEDICAMENTRESERVOIR & RETAINER SHOULDER FOR ASSEMBLY GRABBING SHEATH/DISPENSINGSPRING 7109 MEDICAMENT RESERVOIR & RETAINER SHOULDER FOR ASSEMBLYPLUNGER 7110 MEDICAMENT RESERVOIR & RETAINER RELEASE TABS ASSEMBLY 8100TORSION SPRING UNCOILING TORSIONAL SPRING 8101 TORSION SPRING RECOILINGTORSIONAL SPRING 8102 TORSION SPRING UNCOILING TORSIONAL SPRINGANTI-ROTATIONAL TAIL 8103 TORSION SPRING UNCOILING TORSIONAL SPRINGHELIX END 8104 TORSION SPRING RECOILING TORSIONAL SPRING ANTI-ROTATIONALTAIL 8105 TORSION SPRING RECOILING TORSIONAL SPRING HELIX END 9100RECOIL SYSTEM RECOIL LOCK 9101 RECOIL SYSTEM RECOILING SPRING TENSIONER9102 RECOIL SYSTEM RECOIL LOCK LIVING HINGE 9103 RECOIL SYSTEM RECOILLOCK ALIGNMENT SLOTS 9104 RECOIL SYSTEM RECOILING TENSIONER SLOT FORWINDING 9105 RECOIL SYSTEM RECOILING TENSIONER SLOT FOR LOCKING 9106RECOIL SYSTEM RECOILING TENSIONER TORSION SPRING SLOT 9107 RECOIL SYSTEMRECOIL LOCK NEEDLE BARREL PIECE

Each numerical value presented herein is contemplated to represent anexemplary minimum value or a maximum value in a range for acorresponding parameter. Accordingly, when added to the claims, theexemplary values provide express support for claiming the range, whichmay lie above or below the numerical value, in accordance with theteachings herein. Every value between the minimum value and the maximumvalue within each numerical range presented herein (including in thechart shown in FIG. 141), is contemplated and expressly supportedherein, subject to the number of significant digits expressed in eachparticular range.

The terms and expressions employed herein are used as terms andexpressions of description and not of limitation and there is nointention, in the use of such terms and expressions, of excluding anyequivalents of the features shown and described or portions thereof. Inaddition, having described certain embodiments of the invention, it willbe apparent to those of ordinary skill in the art that other embodimentsincorporating the concepts disclosed herein may be used withoutdeparting from the spirit and scope of the invention. The structuralfeatures and functions of some embodiments may be arranged in variouscombinations and permutations, and all are considered to be within thescope of the disclosed invention. Unless otherwise necessitated, recitedsteps in the various methods may be performed in any order and certainsteps may be performed substantially simultaneously. Accordingly, thedescribed embodiments are to be considered in all respects as onlyillustrative and not restrictive. Furthermore, the configurationsdescribed herein are intended as illustrative and in no way limiting.Similarly, although physical explanations have been provided forexplanatory purposes, there is no intent to be bound by any particulartheory or mechanism, or to limit the claims in accordance therewith.

What is claimed is:
 1. A compact, high aspect ratio auto-injector fordelivering a medicament dose subcutaneously or intramuscularly, theauto-injector comprising: a sealed housing rotatably retained in acover, the sealed housing comprising an interface to receive user inputto facilitate a manual rotation of the sealed housing relative to thecover from a first locked position to a second unlocked position; abiasing member operable such that when the housing is rotated to theunlocked position, the sealed housing is automatically displaced axiallyrelative to the cover, increasing a height of the auto-injector; amedicament dispensing system disposed within the housing and comprisinga medicament reservoir adapted to contain the dose; and a needleextension mechanism coupled to the medicament reservoir, the needleextension mechanism comprising a curved injection needle adapted to bestraightened during deployment of the needle to facilitate dispensing ofthe dose by the auto-injector. 2.-3. (canceled)
 4. The auto-injectoraccording to claim 1, wherein at least one of the sealed housing, thecover, a label, and a component directly visible to the user comprisesindicia indicating the locked position, the unlocked position, and anarmed position.
 5. (canceled)
 6. The auto-injector according to claim 1,wherein the biasing member comprises a spring that is at least one ofintegrally formed with the sealed housing, integrally formed with thecover, and disposed between the housing and the cover.
 7. Theauto-injector according to claim 1, wherein the auto-injector furthercomprises an interlock, such that the sealed housing cannot be rotatedrelative to the cover or displaced axially relative to the cover withoutremoval of the interlock.
 8. The auto-injector according to claim 1,wherein manual compression of the auto-injector in the armed position,reduces the height of the auto-injector, and activates a mechanism thatstraightens and extends a distal end of the injection needle through thesealed housing, dispenses the dose through the injection needle, andactivates an interlock.
 9. The auto-injector according to claim 8,wherein upon release of manual compression, the biasing memberautomatically displaces the sealed housing axially relatively to thecover, increasing a height of the auto-injector and retracting thedistal end of the injection needle into the sealed housing.
 10. Theauto-injector according to claim 9, wherein the auto-injector furthercomprises an interlock to prevent subsequent manual compression of theauto-injector, thereby rendering the auto-injector single-use.
 11. Theauto-injector according to claim 10, wherein the interlock comprises anabutting structure in the sealed housing and the cover.
 12. Theauto-injector according to claim 1, wherein the medicament dispensingsystem further comprises a plunger within the medicament reservoir andforming a sealed cavity for retaining the dose.
 13. The auto-injectoraccording to claim 12, wherein the medicament dispensing system furthercomprises a dispensing needle in fluidic communication with theinjection needle.
 14. The auto-injector according to claim 13, furthercomprising a flexible tube interconnecting the dispensing needle withthe injection needle.
 15. The auto-injector according to claim 13,wherein the medicament dispensing system further comprises a spring, aretainer, and a locking mechanism such that when the locking mechanismis released, the spring displaces the retainer and forces the dispensingneedle to pierce the plunger to provide fluidic communication with thedose.
 16. The auto-injector according to claim 15, wherein the covercomprises a second trigger to release the retainer and the lockingmechanism.
 17. The auto-injector according to claim 15, wherein thespring further displaces the plunger to pump the dose out of themedicament reservoir and through the dispensing needle to the injectionneedle.
 18. The auto-injector according to claim 15, wherein the springcomprises a compression spring.
 19. The auto-injector according to claim1, wherein the needle extension mechanism further comprises a needlebarrel for supporting the curved injection needle, a spring coupled tothe barrel for rotating the barrel to uncoil the curved injectionneedle, and a barrel locking mechanism to prevent inadvertent rotationof the barrel.
 20. The auto-injector according to claim 19, wherein thespring comprises a torsion spring.
 21. The auto-injector according toclaim 19, wherein the cover forms an aperture through which a distal endof the injection needle passes during rotation of the barrel tostraighten the injection needle.
 22. The auto-injector according toclaim 21, wherein release of the barrel locking mechanism permits thespring to rotate the barrel and deploy the injection needle.
 23. Theauto-injector according to claim 22, wherein the cover comprises a firsttrigger to release the barrel locking mechanism.
 24. The auto-injectoraccording to claim 19, wherein the needle extension mechanism furthercomprises a needle barrel cap to secure a proximal end of the injectionneedle to the needle barrel.
 25. A method of operating a compact, highaspect ratio auto-injector for delivering a medicament dosesubcutaneously or intramuscularly, the auto-injector comprising ahousing, a medicament dispensing system disposed within the housing andcomprising a medicament reservoir adapted to contain the dose, and aneedle extension mechanism coupled to the medicament reservoir, theneedle extension mechanism comprising a curved injection needle, whereinat least one of (i) the housing comprises a sealed housing rotatablyretained in a cover, the sealed housing comprising an interface toreceive user input to facilitate a manual rotation of the sealed housingrelative to the cover from a first locked position to a second unlockedposition and (ii) the needle extension mechanism further comprises aneedle barrel for supporting the curved injection needle, a springcoupled to the barrel for rotating the barrel to uncoil the curvedinjection needle, and a barrel locking mechanism to prevent inadvertentrotation of the barrel, the method comprising the steps of: triggeringdeployment of a distal end of the curved injection needle through anaperture in the cover of the housing to straighten the injection needle;triggering piercing of the medicament reservoir to provide fluidiccommunication between the reservoir and the curved injection needle;dispensing the dose through the injection needle at a desired injectionlocation; and thereafter, retracting the distal end of the injectionneedle into the auto-injector.
 26. The method according to claim 25,wherein the auto-injector further comprises an interlock, such that thehousing cannot be rotated relative to the cover or displaced axiallyrelative to the cover without removal of the interlock.
 27. The methodaccording to claim 25, further comprising the step of: manually rotatingthe housing relative to the cover from the first locked position to thesecond unlocked position, in which the sealed housing is automaticallydisplaced axially relative to the cover to an armed position, increasinga height of the auto-injector.
 28. The method according to claim 27,further comprising the step of determining the locked position, theunlocked position, and the armed position based on indicia on at leastone of the housing, the cover, a label, and a component directly visibleto the user.
 29. The method according to claim 27, further comprisingthe step of adhering the cover to the desired injection location priorto triggering of the auto-injector.
 30. The method according to claim27, wherein the step of triggering piercing of the medicament reservoircomprises manually compressing the auto-injector when the auto-injectoris in the armed position, which comprises activating the medicamentdispensing mechanism triggering piercing of a plunger within themedicament reservoir with a distal end of a dispensing needle. 31.-38.(canceled)
 39. The method according to claim 30, wherein the step oftriggering piercing of the medicament reservoir further comprisespumping the dose out of the reservoir to the injection needle.
 40. Themethod according to claim 30, where in the step of manually compressingthe auto-injector when the auto-injector is in the armed positionfurther comprises activating the needle extension mechanism triggeringthe deployment of the distal end of the curved injection needle throughthe aperture in the cover.
 41. The method according to claim 40, whereinthe step of activating the needle extension mechanism comprisingdeploying the distal end of the curved injection needle through theaperture in the cover further comprises rotating the needle barrel todrive the distal end of the curved injection needle through theaperture.
 42. The method according to claim 25, wherein the step ofretracting the distal end of the injection needle into the auto-injectorresults from releasing manual compression of the auto-injector.
 43. Themethod according to claim 25, further comprising the step of removingthe auto-injector from the desired injection location after dispensingthe dose.
 44. The method according to claim 25, further comprising thestep of automatically interlocking the auto-injector after retraction ofthe injection needle to prevent reuse of the auto-injector and exposureof a distal end of the injection needle.
 45. The method according toclaim 25, further comprising the step of disposing of the auto-injectorafter a single use.
 46. A compact, high aspect ratio auto-injector fordelivering a medicament dose subcutaneously or intramuscularly, theauto-injector comprising: a housing; a medicament dispensing systemdisposed within the housing and comprising a medicament reservoiradapted to contain the dose; and a needle extension mechanism coupled tothe medicament reservoir, the needle extension mechanism comprising (i)a curved injection needle adapted to be straightened during deploymentof the needle to facilitate dispensing of the dose by the auto-injector,(ii) a needle barrel for supporting the curved injection needle, (iii) abarrel spring coupled to the barrel for rotating the barrel to uncoilthe curved injection needle, and (iv) a barrel locking mechanism toprevent inadvertent rotation of the barrel.
 47. The auto-injectoraccording to claim 46, wherein the housing comprises a sealed housingrotatably retained in a cover.
 48. The auto-injector according to claim47, where the housing further comprises an interface to receive userinput to facilitate a manual rotation of the housing relative to thecover from a first locked position to a second unlocked position. 49.The auto-injector according to claim 48, wherein at least one of thehousing, the cover, a label, and a component directly visible to theuser comprises indicia indicating the locked position, the unlockedposition, and an armed position.
 50. The auto-injector according toclaim 48, wherein the auto-injector further comprises a biasing member,such that when the housing is rotated to the unlocked position, thesealed housing is automatically displaced axially relative to the cover,increasing a height of the auto-injector.
 51. The auto-injectoraccording to claim 50, wherein the biasing member comprises a biasingspring that is at least one of integrally formed with the housing,integrally formed with the cover, and disposed between the housing andthe cover.
 52. The auto-injector according to claim 50, wherein theauto-injector further comprises an interlock, such that the housingcannot be rotated relative to the cover or displaced axially relative tothe cover without removal of the interlock.
 53. The auto-injectoraccording to claim 50, wherein manual compression of the auto-injectorin an armed position, reduces the height of the auto-injector, andactivates a mechanism that straightens and extends a distal end of theinjection needle through the housing, dispenses the dose through theinjection needle, and activates an interlock.
 54. The auto-injectoraccording to claim 53, wherein upon release of manual compression, thebiasing member automatically displaces the housing axially relatively tothe cover, increasing a height of the auto-injector and retracting thedistal end of the injection needle into the housing.
 55. Theauto-injector according to claim 54, wherein the auto-injector furthercomprises an interlock to prevent subsequent manual compression of theauto-injector, thereby rendering the auto-injector single-use.
 56. Theauto-injector according to claim 55, wherein the interlock comprises anabutting structure in the housing and the cover.
 57. The auto-injectoraccording to claim 46, wherein the medicament dispensing system furthercomprises a plunger within the medicament reservoir and forming a sealedcavity for retaining the dose.
 58. The auto-injector according to claim57, wherein the medicament dispensing system further comprises adispensing needle in fluidic communication with the injection needle.59. The auto-injector according to claim 58, further comprising aflexible tube interconnecting the dispensing needle with the injectionneedle.
 60. The auto-injector according to claim 58, wherein themedicament dispensing system further comprises a retainer spring, aretainer, and a retainer locking mechanism such that when the retainerlocking mechanism is released, the retainer spring displaces theretainer and forces the dispensing needle to pierce the plunger toprovide fluidic communication with the dose.
 61. The auto-injectoraccording to claim 60, wherein the cover comprises a second trigger torelease the retainer and the retainer locking mechanism.
 62. Theauto-injector according to claim 60, wherein the retainer spring furtherdisplaces the plunger to pump the dose out of the medicament reservoirand through the dispensing needle to the injection needle.
 63. Theauto-injector of claim 60, wherein the retainer spring comprises acompression spring.
 64. The auto-injector according to claim 46, whereinthe barrel spring comprises a torsion spring.
 65. The auto-injectoraccording to claim 46, wherein the cover forms an aperture through whicha distal end of the injection needle passes during rotation of thebarrel to straighten the injection needle.
 66. The auto-injectoraccording to claim 65, wherein release of the barrel locking mechanismpermits the barrel spring to rotate the barrel and deploy the injectionneedle.
 67. The auto-injector according to claim 66, wherein the covercomprises a first trigger to release the barrel locking mechanism. 68.The auto-injector according to claim 46, wherein the needle extensionmechanism further comprises a needle barrel cap to secure a proximal endof the injection needle to the needle barrel.
 69. The auto-injectoraccording to claim 1, wherein the cover comprises a tactile surfaceadapted to at least one of (i) provide adhesion to an injectionlocation, (ii) aid in handling the auto-injector during manualcompression of the sealed housing into the cover for performing aninjection, and (iii) provide an indication of an orientation of theauto-injector.
 70. The auto-injector according to claim 1, wherein thebiasing member is further operable such that when the housing is rotatedto the unlocked position, the sealed housing is automatically rotatedrelative to the cover.
 71. The auto-injector according to claim 47,wherein the cover comprises a tactile surface adapted to at least one of(i) provide adhesion to an injection location, (ii) aid in handling theauto-injector during manual compression of the sealed housing into thecover for performing an injection, and (iii) provide an indication of anorientation of the auto-injector.
 72. The auto-injector according toclaim 50, wherein the biasing member is further operable such that whenthe housing is rotated to the unlocked position, the sealed housing isautomatically rotated relative to the cover.